The present invention relates to an apparatus capable of enabling a practitioner to thread a suture in a layer of subcutaneous tissue from a remote access point, to surgical methods facilitated by such an apparatus, and to associated tools useful with the apparatus for performing such surgical methods.
Various surgical methods, primarily in the field of plastic surgery, require the placement of a suture deep inside a layer of subcutaneous tissue from a remote access point. The typical procedure used is to first separate the layers of tissue (e.g., the facial tissue) for appropriate access, and to later suture the layers of tissue together, under tension. This, however, requires extensive surgery, which is expensive and which takes a significant amount of time (e.g., a matter of weeks) to heal.
Various procedures have been attempted to reduce the resulting trauma to a patient, the corresponding expense of the procedure, and the time required for recovery.
For example, one attempted procedure has been to implant a device having barbed profiles capable of engaging subcutaneous tissue at a location remote from the point of access. In practice, however, such barbs have been found to be prone to release after a relatively short period of time (on the order of a few months). Release of the barbs then allows the engaged tissue to sag.
Other attempted procedures have made use of suturing devices for facilitating placement of the suture from a remote access point. Such devices, however, are bulky mechanisms which, in practice, require considerable separation of the layers of tissue in order to reach the intended location, and are typically prone to the severing of blood vessels and nerves. Moreover, surgical procedures using such devices are complicated, and typically require the use of an endoscope, adding to the complexity of the desired procedure. Furthermore, such surgical procedures are highly invasive, time consuming and expensive, and require long recovery times.
As a consequence, there has long been a need in surgery, and in particular, facial plastic surgery, for a device which can be used to remotely place a suture and which can enter facial tissue with an incision of minimum size, so that scarring would not then ensue which could mar the resulting appearance. Further required is a surgical procedure that can provide a long term result by minimizing sagging due to migration of the sutures through tissue due to applied stresses, a problem which is commonly referred to in the art as a “cheese wire effect”.
Various suturing instruments are well known in surgical practice, particularly those used in laparoscopic procedures in which the task is to sew together separated tissue, such as incisions made in skin or organs, by remote manipulation. For example, one such instrument is disclosed in U.S. Pat. No. 5,782,845, and includes a first elongated hollow body that can be passed fully through the tissue on one side of a wound or incision, and a second elongated body having an aperture which is passed fully through the other side of the wound or incision. The two bodies are brought together by an alignment device to achieve closure of the wound and to ensure that the ends of both bodies meet and coincide, employing what is essentially a lateral motion, for the passage of a suture.
However, because the internal side of the tissue typically contains a free medium such as air or a fluid, a suture threaded through the first body can pass through the aperture of the second body and can issue unimpeded into the internal side. Following this, the suture can be extracted by the second elongated body, having the aperture, and can be withdrawn to the exterior of the tissue, where it can be tensioned and knotted with the end of an opposing suture. Instruments of this type provide no spacings, within or between successive suture stitches.
Other suturing instruments are constructed much like hemostats, which employ a pincing motion that operates from a remote pivot, and are similarly suited for joining and attaching remote tissue.
A further consideration is that in practicing certain surgical procedures, particularly including facial plastic surgery, external manipulation is required from a remote access point, unlike wound closure, which requires local manipulation. The elongated hollow body of an instrument of the type disclosed in U.S. Pat. No. 5,782,845, must be guided by the apparatus for alignment with and for passing through a subcutaneous target aperture, and the guiding and docking motion to be employed must be virtually coincident with the axis of the hollow body. Otherwise, bunching of the tissue will occur, causing an unwanted cosmetic effect. For the example of a desired facial cosmetic surgical procedure, an appropriate alignment device must reference as close to the target aperture as is possible to prevent even slight looseness in the alignment mechanism from magnifying and causing misalignment between the hollow body and the aperture, thereby preventing penetration.
For cosmetic reasons, there is also a need to minimize the size of any apertures. Consequently, for facial cosmetic surgery, it is further necessary to use small diameter hollow bodies (preferably, 1.25 mm or smaller) to prevent the scarring of skin tissue. Moreover, to further prevent trauma, the surgical apparatus must be capable of storing the suture ends, for later extraction at a common external location on the face where the exposed ends are to be tensioned and tied together to complete the desired procedure.
A further consideration is that because suture material can buckle when subjected to axial compression, the hollow body must be capable of penetrating the aperture and the tissue by a sufficient distance to make room in the subcutaneous tissue for receiving the suture. Otherwise, the suture material will bunch up, and will fail to deploy to an adequate length for capture and extraction at the aperture. The apparatus could additionally be provided with an aperture which collapses with adequate force to clamp the suture ends during extraction.
Because the known devices were not capable of performing in this manner, it remained desirable to provide a surgical suturing apparatus which could overcome the fundamental deficiencies presented by such devices, to carry out a desired surgical procedure.
To this end, both U.S. Provisional Application No. 60/962,031 and International Application No. PCT/US2008/009012 disclosed various alternative embodiments of an apparatus which could place a suture deep inside a layer of subcutaneous tissue, from a remote access point, and which could be used to implement a surgical method for performing desired surgical procedures.
It has since been determined that other alternative embodiment devices can be developed for placing a suture deep inside a layer of subcutaneous tissue, from a remote access point, and for implementing surgical methods for performing desired surgical procedures, in addition to those disclosed in U.S. Provisional Application No. 60/962,031 and International Application No. PCT/US2008/009012.